job description
Join Forefront Medical Investment Pte Ltd, a leading global medical device contract manufacturer, as a Validation Engineer in the vibrant heart of Bali. With operations spanning Singapore, Changzhou, and Xiamen, we are committed to delivering high-quality medical devices that meet rigorous industry standards. In this role, you will play a pivotal part in ensuring the validation and compliance of our manufacturing processes, contributing to our mission of advancing healthcare solutions worldwide.
Based in the picturesque region of Canggu, this position offers a unique blend of professional growth and an inspiring work environment. You will collaborate with cross-functional teams to develop and execute validation protocols, ensuring that our products meet regulatory requirements and exceed customer expectations. If you are passionate about quality assurance and eager to make a tangible impact in the medical device industry, we invite you to apply and become part of our innovative team.
Responsibility
- Develop and execute validation protocols for medical device manufacturing processes, ensuring compliance with ISO 13485, FDA, and other regulatory standards.
- Conduct risk assessments and implement mitigation strategies to ensure product safety and efficacy.
- Collaborate with engineering, production, and quality assurance teams to identify and resolve validation-related issues.
- Prepare and maintain validation documentation, including reports, protocols, and standard operating procedures (SOPs).
- Perform equipment qualification (IQ, OQ, PQ) and process validation activities.
- Support internal and external audits by providing validation-related data and documentation.
- Stay updated with industry trends and regulatory changes to ensure continuous improvement in validation processes.
- Train and mentor junior team members on validation best practices and procedures.
Qualifications
- Bachelor's degree in Engineering, Biomedical Engineering, or a related field. Advanced degrees are a plus.
- Minimum of 3 years of experience in validation engineering within the medical device or pharmaceutical industry.
- Strong knowledge of regulatory standards such as ISO 13485, FDA 21 CFR Part 820, and EU MDR.
- Experience with validation software tools and statistical analysis methods.
- Excellent problem-solving skills and attention to detail.
- Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
- Ability to manage multiple projects and meet deadlines in a fast-paced environment.
- Certification in quality management (e.g., ASQ CQE, CQA) is highly desirable.